Medtronic Inc. has announced that it has received United States Food and Drug Administration (FDA) approval under a humanitarian device exemption (HDE) for the Medtronic Enterra II System.
The system is used to treat chronic intractable nausea and vomiting associated with gastroparesis of diabetic or unknown origin when more conservative treatments fail or cannot be tolerated.
AdvertisementMedtronic Enterra Therapy consists of a small medical device called a neurostimulator which is implanted under the skin usually in the lower abdominal region.
Two insulated wires called leads are implanted in the stomach wall muscle and then connected to the neurostimulator which delivers mild electrical pulses through the leads to stimulate the smooth muscles of the lower stomach.
After the device is implanted the doctor uses a handheld external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs. Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis including chronic nausea and vomiting" said Dr. Parkman, M.D. Professor of Medicine at Temple University School of Medicine and Director of the GI Motility Laboratory at Temple University Hospital. "The new advanced system simplifies the implantation process and is easy to program."